Horizon Pharma, a US-based drug company, has moved court against Mumbai-headquartered Lupin over what it calls ‘patent infringement’. Horizon decided to take legal action after Lupin filed an abbreviated new drug application (Anda) for a generic version of Pennsaid, a non-steroidal anti-inflammatory drug.
Horizon, in a recent case filed in the District Court of New Jersey, asserted its rights over four patents related to manufacturing of Pennsaid two per cent (the formulations comprise two per cent diclofenac sodium). The case is yet to be heard.
Lupin did not comment on the matter. But, sources close to the development have confirmed the lawsuit.
According to the plea, Lupin should be allowed to market Penn said two per cent only after the drug’s patent duration with Horizon expires. Horizon has also asked for monetary benefit, should Lupin be able to sell Penn said two per cent in the US before the patent expires.
Horizon had purchased the right to sales and marketing of Pennsaid from Canada-based Nuvo Pharmaceuticals in 2014. Horizon bought the right to market and sell the drug in the US for $45 million. Nuvo, however, retains the right to market the product outside the US.
Horizon had earlier filed a suit against Sun Pharmaceuticals’ US subsidiary Taro Pharmaceuticals for infringement of patent for the same drug – Pennsaid. This followed Taro filing an Anda with the US Food and Drug Administration for a generic version of Pennsaid. Subsequently, Taro and Horizon reached an agreement, whereby Taro got the non-exclusive right to market the generic product.
Penn said two per cent was a major success in 2015, contributing $147 million in sales for a product that cost Horizon $45 million to acquire.
Horizon, in a recent case filed in the District Court of New Jersey, asserted its rights over four patents related to manufacturing of Pennsaid two per cent (the formulations comprise two per cent diclofenac sodium). The case is yet to be heard.
Lupin did not comment on the matter. But, sources close to the development have confirmed the lawsuit.
According to the plea, Lupin should be allowed to market Penn said two per cent only after the drug’s patent duration with Horizon expires. Horizon has also asked for monetary benefit, should Lupin be able to sell Penn said two per cent in the US before the patent expires.
Horizon had purchased the right to sales and marketing of Pennsaid from Canada-based Nuvo Pharmaceuticals in 2014. Horizon bought the right to market and sell the drug in the US for $45 million. Nuvo, however, retains the right to market the product outside the US.
Horizon had earlier filed a suit against Sun Pharmaceuticals’ US subsidiary Taro Pharmaceuticals for infringement of patent for the same drug – Pennsaid. This followed Taro filing an Anda with the US Food and Drug Administration for a generic version of Pennsaid. Subsequently, Taro and Horizon reached an agreement, whereby Taro got the non-exclusive right to market the generic product.
Penn said two per cent was a major success in 2015, contributing $147 million in sales for a product that cost Horizon $45 million to acquire.